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本帖最后由 julia朱玉姣 于 2016-7-8 08:44 编辑
FDA issues new Draft Guidance on ElementalImpurities FDA签发元素杂质指南草案 The ICH Q3D " Guideline for Elemental Impurities" was issued in December2014 and recommended for adoption in the regulations portfolio of the ICHregions Europe, USA and Japan according to the ICH step-by-step procedure (Step5). With the publication of the "ICH guideline Q3D on elementalimpurities" (EMA/CHMP/ICH/353369/2013) in August 2015 the European Medicines Agency (EMA)implemented this step and determined June 2016 (for medicinal products to benewly approved) and December 2017 (for already approved medicinal products) asthe dates for the Guideline to come into effect. The FDA took over the ICH Q3D Guideline in September 2015. ICH Q3D“元素杂质指南”于2014年12月发布，建议ICH各方采用（第5阶段）。随着“ICH Q3D指南：元素杂质（EMA/CHMP/ICH/353369/2013）”于2015年8月公布，EMA实施了此步，确定2016年6月（新批准药品）和2017年12月（已批准的药品）作为指南的生效日期。FDA已于2015年9月采用了ICH Q3D指南。 2016年6月30日，FDA行业指南“药品中的元素杂质”作为草案签发，现在公开60天征求意见。 The requirements of the Guidance apply to 指南要求适用于： - New compendial and noncompendial NDA or ANDA drug products
- 药典和非药典新NDA和ANDA药品
- Drug products not approved under an NDA or ANDA - as, e.g., compendial and noncompendial nonprescription OTC products.
- 不是采用NDA或ANDA程序批准的药品---例如药典和非药典非处方OTC药品
Compendial medicinal products are generally supposedto fulfil the requirements defined in the general USP Chapters < 232> und < 233>. However, in thefollowing cases the provisions of ICH Q3D have to be met: 药典药品一般是要满足USP章节<232>和<233>通则的要求。但是，以下情况则必须满足ICH Q3D的要求： - For noncompendial drug products,
- 非药典药品
- For metallic impurities listed only in ICH Q3D but not in the general USP Chapters <232> and <233>.
- 金属杂质仅在ICH Q3D中列出，但没有在USP <232>和<233>中列出
Correspondingly these provisions do also apply forchanges to approved medicinal products, made with the goal to fulfil therequirements of the chapters <232> and <233>respectively of ICH Q3D. For compendial medicinal products the result ofthe change must be the compliance with <232> and <233>,noncompendial products have to comply with the provisions of ICH Q3D. 对应地，这些条款也适用于已批准药品的变更，其目标是满足第<232>和<233>即ICH Q3D的要求。对于药典药品，变更结果必须符合<232>和<233>的要求，非药典药品必须符合ICH Q3D的条款。 The FDA generally considers these kind of changes aslow risk with regard to negative effects on identity, strength, quality, purityor potency. For that reason they are not subject to the CBE change procedureand can be reported to the FDA as part of the annual report. FDA一般考虑这类变更从其对鉴别、剂量、质量、纯度或效价的不良影响来说认为是为低风险变更。因此，并不需要经过CBE变更程序，可以作为年报的一部分呈报FDA。 The general USP Chapter <232> only comprises thePDE values of 15 elements, while ICH Q3D covers 24 elements. Otherwise bothchapters were adapted to ICH Q3D and issued in the second supplementary volumeof USP 38-NF 33 on 1 December 2015. However, both chapters can only be appliedto compendial products starting on 1 January 2018 - the date mentioned in theGeneral Notices 5.60.30 "Elemental Impurities in USP Drug Products andDietary Supplements". This is nearly the date (December 2017) determinedfor the application of ICH Q3D respectively the European Guideline(EMA/CHMP/ICH 353369/2013). USP通则<232>只包括了15种元素的PDE值，而ICHQ3D则包括了24种元素。其它方面，两章都采用了ICH Q3D的内容，发布在2015年12月1日USP38-NF33增补卷上。但是，2章对药典药品生效是从2018年1月1日开始的---在通则5.60.30“USP药品和膳食补充剂里的元素杂质”里提到。这个日期与ICH Q3D对应的欧洲指南（EMA/CHMP/ICH 353369/2013）生效日期（2017年12月）接近。
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